欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/0498/001
药品名称Zopiclone-Apex 7,5 mg tabletten, omhulde tabletten
活性成分
    • zopiclone 7.5 mg
剂型Film-coated tablet
上市许可持有人Apex Pharmaceuticals Ltd. 36 Saint George Street Mayfair W1S 2FW London/UK UK
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Denmark (DK)
      Zolpiclone "Aprex"
许可日期2004/06/16
最近更新日期2011/01/12
药物ATC编码
    • N05CF01 zopiclone
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Article 4.8(a)(iii), first paragraph
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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    市场状态Positive
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